According to the statement, “there is no such term as ‘cosmeceuticals’ in terms of legislation, not only in China, but also in most other countries around the world. Because the general consensus among cosmetic regulatory agencies across all countries/areas is to avoid any confusion between the terms of cosmetics and medicines/pharmaceuticals. Despite the fact that in some countries, certain products in the categories of drug or quasi drug are allowed to be used as cosmetics, such products shall meet all regulatory requirements of drug or quasi drug, and therefore ‘cosmeceuticals’ do not exist by cosmetic regulatory standards.”
“And according to the current Cosmetic Hygiene Supervision Regulations (provision No.12 and No.14), no medical indication/efficacy/therapeutic effect/term is permitted on the labelling, packaging and/or product instruction of any cosmetic product. It is illegal for any product filed/registrated as cosmetic to claim such concept as ‘cosmeceuticals,’ ‘medical skin care’ or any other similar wording,” the agency reiterates.
The same statement also clarifies the legal status of two trending ingredients in cosmetic applications, oligopeptide-1 and human oligopeptide-1 (EGF). As opposed to oligopeptide-1 listed as a skin conditioner in the Catalogue of Existing Cosmetic Ingredients(IECIC2015), Human Oligopeptide-1 (EGF) has never been allowed in cosmetic applications, despite its use in medical treatments for topical burns and wounds, according to the agency.
As the statement explains, it is difficult for EGF to penetrate through a healthy skin barrier due to its high molecular weight, while for an impaired skin barrier it could cause potential safety concerns.
“On the ground of efficacy and safety, EGF is banned from being used as a cosmetic ingredient, ” the agency concluded. “It is illegal for any cosmetic formulary to be added with or claim to contain Human Oligopeptide-1 or EGF.”
The statement publicized on NMPA’s official website, seems to have caught the beauty industry off guard. As a matter of fact, the term “cosmeceuticals” first came under CFDA scrutiny back in 2010, when the agency issued notices on strengthening supervision and inspection of cosmetic product with any medical-related term. This comes as a surprise, however, as there has been little enforcement of the measure, even as cosmeceutical sales have surged in recent years.
While many industry experts are still debating the short-term and long-term prospects of cosmeceuticals, the market was quick to respond this time. During the past week, nearly all leading e-commerce platforms, including Tmall and JD, have moved to block the searches of “cosmeceuticals”and “EGF”under increasing media scrutiny. And major brands in the sector are taking actions as well.
For example, Winona, a local brand which has emerged as “cosmeceuticals”and “dermatologist/medical skin care”and achieved great success in China recently, is shifting to strengthen its positioning on“for sensitive skin supported by dermatology.” The brand topped the chart of best-selling cosmeceutical brands”in last year’s Tmall Double 11 Shopping Festival.
Multinationals are adapting, too. At an official launching event for CeraVe on the same day the statement was issued, L’Oréal played down the brand’s positioning as “cosmeceuticals”in overseas markets. Instead, the group noted that it would comply with China regulations and focus more on product safety, health benefit and scientific validation. As the forth brand from the group’s Active Cosmetics Division in China, CeraVe claims itself to be an expert on dry/sensitive skin barrier repair recommended by American dermatologists.
While the talk of the potential for“cosmeceuticals,”or to be precise, functional cosmetics for skin in suboptimal health status, won’t go away in China, EGF is certainly a no-go. Once hailed as a silver bullet for various skin concerns, EGF is quickly falling out of favor, leading the industry to ponder the future of freeze-dried powder, a booming form of product which largely builds its success on EGF.•